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Re: gi197845 post# 325

Sunday, 05/27/2018 2:23:28 PM

Sunday, May 27, 2018 2:23:28 PM

Post# of 785
I don't believe they will be redoing the TLando study but only Ambulatory Blood Pressure effects and proving that in vivo conversion does not happen. After the 1st CRL, I think the meeting with the FDA occurred about 2 months after but I may be wrong.

I'm guessing the next catalyst will be FDA response to proposed ABPM study and potentially and partner for the PTB pill. CEO said that they are aggressively pursing a partner so I'm guess that could happen any time now.

I also think TLando will eventually get approved. The good news is LPCN should now know what concerns the FDA and the future clinical trials for the once a day pill should address all concerns being presented now assuming the fda doesn't come up with new issues.

LPCN should need to raise money. They just secured a 10M loan back in January.

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